CARDIOVASCULAR JOURNAL OF AFRICA • Vol 23, No 8, September 2012
AFRICA
471
Drug Trends in Cardiology
High patient compliance with nicacin/laropiprant in large clinical
trial
Interim safety and tolerability results from HPS-2 THRIVE study released at 2012 ESC congress
Of the patients randomised to niacin/
laropiprant in the HPS-2 THRIVE study,
75%
remained compliant after three
years of therapy with the combination
of an extended-release niacin and the
non-flushing agent, laropiprant.*
HPS-2 THRIVE is a heart-protection
study focused on treating high-density
lipoprotein (HDL) cholesterol to reduce
the incidence of vascular events.
It is being undertaken in both Europe
and China, involving more than 25 000
patients. The clinical outcome data for the
four years’ follow up of the study will be
available early next year.
Speaking at the ESC hotline session,
Prof Jane Armitage, University of
Oxford, pointed out that laropiprant, the
prostaglandin D2 receptor antagonist was
developed following the discovery of the
DP1 receptor, which increases blood flow
in the skin, causing flushes.
‘
The drop-out of eligible patients
prior to randomisation in the niacin/
laropiprant arm was 33% compared
to 11% on placebo and entering the
LDL-stabilisation phase.’ The drop-outs
in the niacin group were mainly due
to muscular symptoms and the well-
recognised gastrointestinal symptoms,
interference in diabetes control, as well
as skin reactions (flushing, itching and
rashes). ‘The purpose of this phase was
of course to exclude patients who could
not tolerate the drug’, Dr Armitage noted.
In the study, the LDL cholesterol
levels were well controlled (1.64 mmol/l)
on background statin therapy. These were
further lowered by the niacin/liropiprant
treatment by 20%. HDL-C levels increased
by 17%, apoplipoprotein B decreased by
14%
and apolipoprotein A was increased
by 16%. ‘This is a very useful alteration
in lipid risk’, Dr Armitage noted.
Patients were recruited in China and
Europe, and 80% were men, mainly with
a history of coronary artery disease, and
25%
had diabetes.The pre-specified safety
points related to muscle and liver function,
with myopathy and rhabdomyolysis being
indicative of worsening kidney function.
The reasons for stopping the active
medication during the trial mirrored that
of the pre-randomisation trial.
‘
It is important to note that the
increase in myopathy seen in the trial
has been largely driven by the higher
rates among patients of Chinese ancestry,
which was six-fold higher than in the
Caucasian population. The majority of
these cases occurred in the first year after
randomisation’, Dr Armitage said. ‘With
regard to liver function, there was very
little difference between the two arms
of the trial; placebo and active niacin/
laropiprant therapy.
In conclusion, Dr Armitage pointed
out that this is the largest trial of lipid-
modification therapy to date. With regard
to safety, there were no other adverse
effects other than those discussed above.
*
This new combination has recently been
launched in South Africa by MSD.
HEALTHCARE
